PregnancyNCT06476626
Maternal Reflective Functioning During the Transition to Motherhood
A study testing Maternal Reflective Function Workshop in people with Pregnancy and Primiparous Women, run by University of Haifa at 1 site in Israel.
Trial summary
The goal of this clinical trial is to learn about Maternal Reflective Function (MRF) during the transition to motherhood. The main questions it aims to answer are: Does MRF mediates the connection between risk factors for mental health difficulties during first pregnancy and motherhood (the transition to motherhood)… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Primiparous Women
- What is being tested?
- Maternal Reflective Function Workshop
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Jul 2024to 30 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- pregnant women in 27-30 weeks pregnant in enrollment
- speak read and understand Hebrew
- Has a connection to internet and ZOOM platform.
- Ready to participate in a group workshop
Who cannot join
- Women who can\'t participate in a online workshop due to physical or mental health difficulties.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site
University of Haifa
Haifa, 3103301
Lee Barel Refaeli, PhD student, 972-504084447, LEEBAREL@GMAIL.COM
Barel Refaeli, 0504084447, LEEBAREL@GMAIL.COM
About this study
Official title: Maternal Reflective Functioning During the Transition to Motherhood as a Protective Factor in the Relationship Between Personal and Environmental Characteristics and the Mental Health of Both the Mother and the Infant
The goal of this clinical trial is to learn about Maternal Reflective Function (MRF) during the transition to motherhood. The main questions it aims to answer are:
Does MRF mediates the connection between risk factors for mental health difficulties during first pregnancy and motherhood (the transition to motherhood) and outcomes related to the mother, the infant, and their relationship.
Participants will:
Answer questionnaires and clinical interviews during pregnancy and after birth of the first child (twice at third trimester, 1 and 3 months after birth).
intervention group will participate in an online short intervention to enhance MRF.
Read the detailed description
Using this trial, the investigators will be able to better understand rather MRF moderate the connection between risk factors to outcomes after birth related to both the mother and the infant. Using RCT design we will be able to understand mechanism of change.
- Conditions
- Pregnancy, Primiparous Women
- Being tested
- Maternal Reflective Function Workshop
- Keywords
- pregnancy, primiparous women, anxiety, depression, stress, mentalization, reflective function
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maternal Reflective Function WorkshopOther
4 session group online intervention focused on psycho-educational knowledge regarding emotional regulation and specifically MRF. group size- up to 15 participants. 2 sessions will be during pregnancy and 2 sessions will taken place 1 and 3 months after birth.
| Study group | Role | What they receive |
|---|---|---|
| Maternal Reflective Functioning intervention group | Experimental | Will participate in a 4 session online psycho-educational workshop during pregnancy and after birth, focused on MRF. Receives: Other: Maternal Reflective Function Workshop |
| Wiat-list control group | No intervention | group will undergo same measurements points with no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Reflective Functioning questionnaires
Will be measured using Parental Reflective Function questionnaires for pregnancy P-PRFQ (Pajulo et al., 2015) and after birth (Parental Reflective Functioning Questionnaire PRFQ, Luyten et al., 2017). Likert Scale from 1 (Greatly disagree) to 7 (Greatly agree).
Measured: Twice in third trimester of pregnancy (Before and after intervention), 1 and 3 months after birth.
Maternal Reflective Functioning interviews
Will be measured using Pregnancy Interview (PI, Slade et al., 1987; Slade, 2003) before labor, and Parental Developmental Interview (PDI-R2 short form, Slade et al., 2003) after labor. Reflective Function Coding Scale- from -1 (No Reflective Function) to 9 (Very high Reflective Function)
Measured: Once in third trimester of pregnancy ,1 months after birth.
Secondary outcomes (12)
Depression.
depression level before, during and after pregnancy and birth, using Edinburgh Postnatal Depression Scale (EPDS, Cox, Holden, \& Sagovsky, 1987). Likert Scale from 1 (Most of the time) to 4 (Almost never).
Measured: Third trimester of pregnancy, 1 and 3 months after birth.
Anxiety
Anxiety level before, during and after pregnancy and birth using Depression Anxiety Stress Scale (DASS-21 short form, Lovibond \& Lovibond, 1995 ). Likert Scale from 0- Does not describe my situation at all, to 3- Describes my situation very much.
Measured: Third trimester of pregnancy, 1 and 3 months after birth.
Exposure to traumatic life events
exposure to ongoing war and political violence in the region using Political Life Events (PLE; Based on Slone et al., 1997, elaborated and adjusted by Yael Meir \& Yael Enav, 2024, not published). Yes/No question and if Yes answered- Likert Scale from 1- Not at all to 5- Very much.
Measured: At enrollment.
Social Support
Social support before and during pregnancy using Multidimensional Scale of Perceived Social Support (MSPSS, Zimet et al., 1988). Likert Scale from 1- Very agree, to 7- Very disagree.
Measured: Third trimester of pregnancy, 1 and 3 months after birth.
Relationship satisfaction
Relationship satisfaction before and during pregnancy using Couple satisfaction index (CSI-16, Funk \& Rogge, 2007). Likert Scale from 0- Not true at all, to 5- Very true.
Measured: Third trimester of pregnancy, 1 and 3 months after birth.
High risk pregnancy
Medical high risk during pregnancy using a single question in initial demographic and personal details questionnaire.
Measured: At enrollment.
Cognitive bias
Cognitive bias before, during and after pregnancy and birth using an go-no-go, infants expression interpretation, and focus of attention assignments.
Measured: Third trimester of pregnancy, 3 months after birth.
Mother-infant bonding
Mother-infant bonding before birth using Prenatal Attachment Inventory (PAI: Muller \& Mercer, 1993) after birth using Postpartum Bonding Questionnaire (PBQ, Brockington et al, 2006 ). PAI Likert Scale from 1- Almost never, to 4- Almost always.
Measured: Third trimester of pregnancy, 1 and 3 months after birth.
Mother Emotional Regulation
Measured using Emotional Regulation Questionnaire (ERQ, Gross \& John, 2003). Likert Scale from 1- Strongly disagree to 7- Strongly agree. PBQ Likert Scale from 1- Never to 6- Always
Measured: Third trimester of pregnancy, 1 and 3 months after birth.
Infant weight
Gain of weight using a single question regarding infant's weight.
Measured: 1 and 3 months after birth.
Maternal self-efficacy
Measured using Maternal self-efficacy Scale (Kestler-Peleg et al., 2015). Likert Scale from 1- Not at all, to 4- Very much.
Measured: 1 and 3 months after birth.
Quality of sleep
Quality of sleep using Brief Infant Sleep Questionnaire (BISQ; Sade, 2004). Likert Scale from 1- Not at all to 4- Usually.
Measured: 1 and 3 months after birth.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start15 Jul 2024 (estimated)
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Haifa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yael Enav, University of Haifa
- Investigators
- Yael Enav, Phd, Principal investigator, University of Haifa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06476626
- Sponsor's protocol ID
- 086/24
- Status last verified
- Jul 2024
- First submitted
- 6 Jun 2024
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD excluding personal information given by participants in interview (records and transcripts), however coded information for these interview will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Reflective Functioning During the Transition to Motherhood as a Protective Factor in the Relationship Between Personal and Environmental Characteristics and the Mental Health of Both the Mother and the Infant
- ClinicalTrials.gov ID
- NCT06476626
- Acronym / sponsor ID
- 086/24
- Conditions
- Pregnancy, Primiparous Women
- Keywords
- pregnancy, primiparous women, anxiety, depression, stress, mentalization, reflective function
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of HaifaUniversity, hospital or other
- Study start
- 15 Jul 2024 (estimated)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 26 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn about Maternal Reflective Function (MRF) during the transition to motherhood. The main questions it aims to answer are:
Does MRF mediates the connection between risk factors for mental health difficulties during first pregnancy and motherhood (the transition to motherhood) and outcomes related to the mother, the infant, and their relationship.
Participants will:
Answer questionnaires and clinical interviews during pregnancy and after birth of the first child (twice at third trimester, 1 and 3 months after birth).
intervention group will participate in an online short intervention to enhance MRF.
Detailed description
Using this trial, the investigators will be able to better understand rather MRF moderate the connection between risk factors to outcomes after birth related to both the mother and the infant. Using RCT design we will be able to understand mechanism of change.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maternal Reflective Functioning intervention group | Experimental | Other: Maternal Reflective Function WorkshopWill participate in a 4 session online psycho-educational workshop during pregnancy and after birth, focused on MRF. |
| Wiat-list control group | No intervention | –group will undergo same measurements points with no intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- pregnant women in 27-30 weeks pregnant in enrollment
- speak read and understand Hebrew
- Has a connection to internet and ZOOM platform.
- Ready to participate in a group workshop
Key exclusion criteria (1 listed)
- Women who can\'t participate in a online workshop due to physical or mental health difficulties.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maternal Reflective Function Workshop4 session group online intervention focused on psycho-educational knowledge regarding emotional regulation and specifically MRF. group size- up to 15 participants. 2 sessions will be during pregnancy and 2 sessions will taken place 1 and 3 months after birth. | Other | Maternal Reflective Functioning intervention group |
Primary outcome
Maternal Reflective Functioning questionnaires
Time frame: Twice in third trimester of pregnancy (Before and after intervention), 1 and 3 months after birth.
Will be measured using Parental Reflective Function questionnaires for pregnancy P-PRFQ (Pajulo et al., 2015) and after birth (Parental Reflective Functioning Questionnaire PRFQ, Luyten et al., 2017). Likert Scale from 1 (Greatly disagree) to 7 (Greatly agree).
Maternal Reflective Functioning interviews
Time frame: Once in third trimester of pregnancy ,1 months after birth.
Will be measured using Pregnancy Interview (PI, Slade et al., 1987; Slade, 2003) before labor, and Parental Developmental Interview (PDI-R2 short form, Slade et al., 2003) after labor. Reflective Function Coding Scale- from -1 (No Reflective Function) to 9 (Very high Reflective Function)
12 secondary outcomes
Depression.
Time frame: Third trimester of pregnancy, 1 and 3 months after birth.
Anxiety
Time frame: Third trimester of pregnancy, 1 and 3 months after birth.
Exposure to traumatic life events
Time frame: At enrollment.
Social Support
Time frame: Third trimester of pregnancy, 1 and 3 months after birth.
Relationship satisfaction
Time frame: Third trimester of pregnancy, 1 and 3 months after birth.
High risk pregnancy
Time frame: At enrollment.
Cognitive bias
Time frame: Third trimester of pregnancy, 3 months after birth.
Mother-infant bonding
Time frame: Third trimester of pregnancy, 1 and 3 months after birth.
Mother Emotional Regulation
Time frame: Third trimester of pregnancy, 1 and 3 months after birth.
Infant weight
Time frame: 1 and 3 months after birth.
Maternal self-efficacy
Time frame: 1 and 3 months after birth.
Quality of sleep
Time frame: 1 and 3 months after birth.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Individual participant dataSharing planned: Yes. All IPD excluding personal information given by participants in interview (records and transcripts), however coded information for these interview will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yael Enav, Phd principal investigator
University of Haifa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maternal Reflective Function Workshop in people with Pregnancy and Primiparous Women, run by University of Haifa at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lee Barel Refaeli, PhD student (972-504084447, LEEBAREL@GMAIL.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal Reflective Functioning questionnaires (time frame: Twice in third trimester of pregnancy (Before and after intervention), 1 and 3 months after birth.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2024; AzTrials last refreshed its copy on 31 Oct 2026.